This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.One controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Log file analysis was not conducted since this event is related to the controller's display.Analysis of the device revealed that the device met specifications; the device passed visual examination and functional testing.The reported event could not be duplicated at the bench level.The controller's display functioned properly without any anomalies at the bench level.No failure detected, the reported event could not be duplicated at the bench level.The instructions for use (ifu) and patient manual include a warning to keep spare, fully charged batteries and back up controller available at all time.The steps for exchange of batteries and controllers are outlined.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.
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